CHEMOTHERAPY CARE PLAN Document Title: Document Type: Subject: Approved by: Currency: Carboplatin/Etoposide Chemotherapy Clinical Guideline Standard Care Plan 2 Years Review date: Author(s): Standard care plan for Carboplatin and Etoposide Chemotherapy References Skarlos DV et al. (1994) Randomized comparison of etoposide-cisplatin vs. etoposidecarboplatin and irradiation in small-cell lung cancer. A Hellenic Co-operative Oncology Group study. Ann Oncol 5: 601-7 Lo Re et al. (1994) Extrapulmonary small cell carcinoma: a single-institution experience and review of the literature. Ann Oncol 5: 909-13 The Role of Thoracic Radiotherapy as an Adjunct to Standard Chemotherapy in Limited-Stage Small Cell Lung Cancer. Cancer Care Ontario Practice Guidelines Initiative. Guideline #7-13- 3 Patient group Limited stage small-cell lung cancer as part of a sequential chemoradiotherapy regimen. Extensive stage small-cell lung cancer Extra-pulmonary small-cell carcinoma Inclusion criteria Histologically confirmed small cell carcinoma First line chemotherapy for SCLC, or relapse more than 6 months since prior platinum based chemotherapy for SCLC. Adequate bone marrow reserve WCC >3 Filename 1.CarboEtop Standard Care Plan Last modified 27-Mar-15 Last printed 27-Mar-15 Page 1 of 6 Agreed by (on behalf of team) Fiona Blackhall
Plts > 100 Hb >10 (consider transfusion if anaemic) Adequate renal function GFR (Cockcroft-Gault) >40 ml/min ECOG PS 0 and 1 (selected cases with PS 2). Patients who are deemed not fit for doublet chemotherapy i.e. moderate to poor PS or multiple co-morbidities should be considered for single agent Carboplatin. Cautions Brain Metastasis Life expectancy < 4 weeks Co-morbidity preventing safe administration of chemotherapy Second malignancy excluding non melanomatous skin cancers in the past 3 years Anticipated benefit Publication N CR PR SD PD ORR mttp OS Expected toxicity Toxicity CTC G3 4 Alopecia Neutropenia Thrombocytopenia Febrile neutropenia CINV Fatigue Toxic death Initial investigations and work up prior to start of treatment Diagnostic review and work up should usually include: Pathology/Cytology confirmed diagnosis of small cell carcinoma Stage of disease determined and documented CT Abdomen/thorax +/- thorax Bronchoscopy/EBUS - desirable Clinical assessment and documentation of current disease related symptoms Performance status recorded Co-morbidities recorded Smoking status recorded FH recorded Concomitant medications recorded and stopped if necessary Baseline GFR/Creatinine clearance (Cockcroft-Gault). If borderline for isoptope GFR Baseline LFTs, Ca, LHD, FBC, UE Baseline CXR Baseline ECG Page 2 of 6 27/03/2015
Patient supplied with written information leaflet and consented for aims, practicalities and toxicity of Carboplatin Etoposide chemotherapy Plan confirmed with consultant oncologist if 1 st seen by junior college MDT meeting Case must have been through the relevant diagnostic MDT prior to commencing treatment. Overview of treatment programme Drugs and Starting Doses Standard dose regimen: Carboplatin AUC 6 Day 1 / Etoposide 120mg/m2 Days 1,2 and 3 Dose-reduced regimen: Carboplatin AUC 5 Day 1 / Etoposide 100mg/m2 Days 1, 2 and 3 Treatment duration 4 cycles (up to 6 cycles in selected cases) Cycle length 3 weeks Consider discontinuation if: Progressive disease clinically or radiologically (by RECIST criteria where possible) Life threatening toxicity attributed predominantly to chemotherapy, i.e. CTCAE Grades 3-4 toxicities Patient choice Significant change in end organ function i.e. decline in renal function GFR < 40ml/min Significant fall in PS (3 or 4) Exacerbation of co-morbid condition Additional medication Anti-emetics Ondansetron 8mg IV bolus Dexamethasone 8mg IV bolus Metoclopromide (or equivalent) prn Prophylaxis Consider prophylactic antibiotics if evidence of collapse/consolidation/cavitation associated with tumour or if deemed high risk for infection. Levofloxacin 500mg od D8 for 10 days. Page 3 of 6 27/03/2015
Growth factor support Other For patients on sequential chemo-radiotherapy: Consider growth factor support if patients have needed deferrals due to neutropenia or treatment for neutropenic infection. Also consider if deemed particularly high risk for life threatening sepsis. (i.e. prosthetic heart valve). Ratiograstim/Filgrastim 300mcg/480mcg (according to bodyweight) D9 for 7 days. Primary or secondary prophylaxis not routinely indicated for patients undergoing chemotherapy with palliative intent. On treatment assessments and schedule of investigations Visit number Appointment 1 OP clinic consultant appointment 2 OP Appt (optional) 3 Protocol clinic cycle 1 day 1 Visit description CXR CT chest abdo CT brain (optional) ECG Nurse specialist (pathology review- optional) (Isotope GFR optional) Consider Clinical Oncology referral for patients suitable for sequential chemoradiotherapy Review Carboplatin AUC 6 (DR: AUC 5) Etoposide 120mg/m2 (DR: 100mg/m2) Ondansetron 8mg stat then bd for 2days Dexamethasone 8mg stat then 4mg BD 3 days Metoclopramide 10mg tds 7 days Consider: Levofloxacin 500mg po od start day 8, 7 days 4 Protocol clinic cycle 1 day 2 Etoposide 120mg/m2 (DR: 100mg/m2) Ondansetron 8mg prn 5 Protocol clinic cycle 1 day 3 Etoposide 120mg/m2 (DR: 100mg/m2) Ondansetron 8mg prn (GCSF optional) 6 OP day 15 clinic review CXR Page 4 of 6 27/03/2015
7 Protocol clinic cycle 2-4 days 1, 2, 3 8 OP clinic cycle 4 day 15 review 9 OP follow up clinic approx 3 months As per visits 3-6. End of treatment CT scan to be requested at cycle 2. CXR CT CXR Clinical assessment Graded documentation of toxicity Assessment of disease related symptoms Performance status recorded Physical examination/focussed examination performed Fitness for continuation of chemotherapy assessed and documented Laboratory assessment FBC Christie Profile Isotope GFR measurement indicated prior to chemotherapy if borderline calculated GFR. Tumour response assessment Clinical assessment of any palpable masses CXR at day 15 clinic review End of treatment restaging CT scan following completion of 4 cycles of chemotherapy Dose modifications Haematological: Use FBC on day of treatment: WBC Neut Plt Dose adjustment >3.0 >1.5 >100 None 2.0-2.9 <1.4-0.9 50-99 Defer one week then proceed with 20% dose reduction (consider continuing on full dose with GCSF support following deferral on sequential regimen) Infective (GCSF support) Febrile neutropaenia (1 st episode) 4-10) Febrile neutropaenia (2 nd episode) reduction + GCSF Defer one week, then full dose with GCSF (days Defer one week, then proceed with 20% dose Renal: use egfr/edta clearance: >50 Full dose 40-49 Use carboplatin AUC 5. Give etoposide at 75% dose. >40 Omit Biochemical: Bilirubin >1.5xULN omit etoposide, can give carboplatin single agent Page 5 of 6 27/03/2015
AST/ALT >2.5xULN (>5XULN if due to liver metastases) consider carboplatin single agent Haematologic toxicity Hb < 8.0 transfuse 2 units of packed red cells Hb 8-9 with symptoms - transfuse 2 units of packed red cells Plts < 10 or 10-20 with evidence of bleeding - Transfuse platelets (1 adult dose) and dose reduce both drugs to 75% Multiple deferrals due to low counts require investigation and cessation of chemotherapy. Non-haematologic toxicity Any grade 3-4 toxicity should result in the consideration of cessation of chemotherapy. Interpretation of response Tumour Assessment Clinical assessment of palpable tumours Follow up CXR End of treatment restaging CT scan. Post treatment follow-up Clinic review every 3 months at which physical assessment and follow-up CXR will be performed. Subsequent active therapy options For patients with limited stage disease, consider consolidation radiotherapy given sequentially after chemotherapy, depending on performance status. In both adjuvant and palliative treatments without proven intracranial metastasis, consider referral for prophylactic cranial irradiation, ideally by cycle 3 of treatment. PCI should never be given concurrently with chemotherapy. Palliative radiotherapy can also be considered for troublesome local symptoms, e.g. painful bone metastasis, persisting bronchial obstruction by tumour. Treatment options at progression Best supportive care Approved second line treatment, after careful assessment of fitness for chemotherapy and consideration of risks and benefits of further treatment. Clinical trial if appropriate. Palliative radiotherapy for symptom control Other regimens/therapies on approval by DMC/Drugs and therapeutics. Page 6 of 6 27/03/2015